Status:
COMPLETED
Efficacy and Safety of St. John´s Wort/Valerian Extract Versus Placebo in Children and Adolescents With ADHD
Lead Sponsor:
Prof. Huss
Collaborating Sponsors:
Steiner Arzneimittel, Berlin, Germany
Conditions:
ADHD
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
This study will determine the safety and efficacy of an herbal treatment in children and adolescents with ADHD. Study Design: * Randomized * Double Blind (Subject, Caregiver, Investigator, Outcomes ...
Detailed Description
ADHD is a common childhood disorder associated with attention problems and disruptive behavior. Clinical evidence suggests that a herbal drug combination of St. John´s Wort /Valerian extract may be ef...
Eligibility Criteria
Inclusion
- DSM-IV Diagnosis of ADHD
- Score of ADHDRS-IV-Parent Version ≥24
- Sufficient knowledge of the German language
- Written Informed Consent by parents and patients
- Ability to swallow study medication
- Sexually mature and active adolescents with highly effective methods of birth control:
- contraception according to Pearl-Index \< 1
- when use of oral contraceptives, additional methods of contraception (e.g. condoms) are necessary, i.e. double-barrier
Exclusion
- Known hypersensitivity against St. John´s wort or Valerian root or one of the excipients
- Known hypersensitivity of the skin when exposed to sunlight
- All serious internal diseases, and for this reason: Current intake of the following medication:
- Ciclosporin, Tacrolimus, Indinavir and other protease inhibitors in the anti-HIV treatment
- Irinotecan and other cytostatics
- anticoagulants of the Cumarin-type, Digoxin, Amitriptylin, Nortriptyline
- Midazolam, Theophylline or other medication with photosensitive effects
- All severe psychiatric diseases except oppositional defiant disorders (according to items 21-28 SNAP-IV) and conduct disorders (according to items 41-45 SNAP-IV), and for this reason current intake of the following medication: antidepressants and other psychotropic medication
- Indication for hospitalization
- Suicidality (including suicidal thoughts): Score ≥3 in item 10 of MADRS
- Pregnancy, lactation
- IQ \< 70
- Positive screening for metabolites of illegal drugs in urine
- Previous medication with stimulants and/or atomoxetine
- Psychotropic co-medication
- Placement in an institution on official or judicial ruling
- Parallel participation in another clinical trial according to German Drug Law (AMG), or less than 4 weeks ago
- Patients requiring a primary medication with methylphenidate during the study period of 8 weeks
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00782080
Start Date
July 1 2008
End Date
June 1 2010
Last Update
March 13 2014
Active Locations (5)
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1
Rheinhessenfachklinik
Alzey, Germany, 55232
2
DRK Fachklinik für Kinder- und Jugendpsychiatrie
Bad Neuenahr, Germany, 53474
3
Praxis für Kinder- und Jugendpsychiatrie
Berlin, Germany, 10789
4
Charité University
Berlin, Germany, 13353